Ortho-Clinical recalls VITROS OP Reagent Gen 15 (model 680 1997) due to potential lower quality control results, risking delayed patient testing. Affected units have specific lot numbers and expiration dates.
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
Ortho-Clinical is recalling VITROS OP Reagent Gen 15 (model 680 1997) because it may produce lower quality control results, which could delay patient testing if the system fails to run the OP-LO protocol. This affects labs using the reagent for urine opiate testing.
The reagent may generate lower quality control results than expected. If quality control fails, the lab cannot run the OP-LO protocol, potentially delaying patient test results. However, this does not cause injury to users.
Labs that use the VITROS OP Reagent Gen 15 for urine opiate testing are most affected. The risk is low as the issue only impacts quality control results, not patient safety directly.
Check for model number 680 1997 on the reagent package. Look for lot numbers 1527-15-2749 (exp. Nov 2025), 1527-15-2771 (exp. Dec 2025), 1527-15-2818 (exp. Apr 2026), or 1527-15-2871 (exp. May 2026).
Verify the lot number on the reagent package to see if it matches the affected numbers listed in the recall.
The VITROS OP Reagent Gen 15 may generate lower quality control results, which could delay patient testing if the lab cannot run the OP-LO protocol.
The recall does not specify a remedy, so labs should check the lot numbers and contact Ortho-Clinical for further guidance.
No, the recall states the issue only affects quality control results and does not involve injury risks.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-2073-2025 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-2073-2025 from Ortho-Clinical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
